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Analyses will be performed with data from included patients until the end of the inclusion period. The clinical team did not wish to extend the inclusion period in order not to delay the analyses.
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Longitudinal analysis of myocardial function using "Speckle Tracking Echocardiography" STE analysis and prediction of delayed toxic induced cardiomyopathy in young patients who received anthracycline therapy in childhood.
Anthracycline therapy may have short-, medium- or long-term cardiac toxicity that impacts patient's life. The main recognized risk factors for delayed cardiotoxicity are cumulative anthracycline dose, female gender, association with mediastinal radiotherapy and young age at administration. Prediction of delayed cardiotoxicity in children population is still challenging.
The "Speckle Tracking Echocardiography" (STE) method, an innovative echocardiographic technique, analyses the myocardial displacement of natural acoustic markers via a software. The objective of the study is to analyze, in young patients who received anthracycline therapy in childhood, 5-years after their inclusion in the "Speckle Anthra" study and first STE results, the evolution of myocardial function using STE method.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anthra2 | Experimental | Patient will have an echocardiography with speckle tracking analysis 5 years after the end of their participation to "SpeckleAnthra" study (NCT02893787) |
|
| Control | Active Comparator | Cardiac ultrasound analysis with speckle tracking of age- and sex-matched healthy patients in the Anthra2 group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cardiac ultrasound with speckle tracking analysis | Diagnostic Test | Experimental group: cardiac ultrasound with speckle tracking analysis done during a regular cardiac visit planned after receiving cardiotoxic chemotherapy in childhood. Control group: cardiac ultrasound with speckle tracking analysis done during a cardiac visit for minor symptoms (murmur, physical aptitude). Advocated Tomtec software will be used to make post-processing speckle tracking analysis based on 2D ultrasound cineloop acquired during a standard echocardiography. |
| Measure | Description | Time Frame |
|---|---|---|
| Left Ventricle Global Longitudinal 2D strain (LVGLS) expressed in percentage and obtained from cardiac ultrasound cineloop of 2D 4,3 and 2 apical views analyzed by the Tomtec STE Software. | To compare the evolution at 5 years ("Anthra2" study timeframe) of LVGLS obtained by STE analysis on patients treated with anthracyclines in childhood and previously included in first "Speckle Anthra" study, with the normal evolution of this parameter with age in healthy matched volunteers. | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Left Ventricle Ejection fraction (LVEF) by Simpson method (%) | Compare the standard ultrasound parameter LVEF and the LVGLS obtained in "Speckle Anthra 2" on patients treated with anthracyclines in childhood and in the group of healthy volunteers. | The day of inclusion |
| Left ventricular myocardial dysfunction defined by LVEF < 55% |
| Measure | Description | Time Frame |
|---|---|---|
| Known risk factors for cardiotoxicity | To assess the effect of known risk factors for anthracycline cardiotoxicity, the anthracycline cumulative dose will be collected | the day of inclusion |
| Troponin T on the experimental group |
ANTHRA GROUP
Inclusion Criteria:
Exclusion Criteria:
CONTROL GROUP
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| VINCENTI Marie, PH | University Hospital, Montpellier | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pediatric and Congenital Cardiology and Pulmonology Department, Arnaud De Villeneuve University Hospital | Montpellier | 34295 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35167907 | Background | Amedro P, Vincenti M, Abassi H, Lanot N, De La Villeon G, Guillaumont S, Gamon L, Mura T, Lopez-Perrin K, Haouy S, Sirvent A, Cazorla O, Vergely L, Lacampagne A, Avesani M, Sirvent N, Saumet L. Use of speckle tracking echocardiography to detect late anthracycline-induced cardiotoxicity in childhood cancer: A prospective controlled cross-sectional study. Int J Cardiol. 2022 May 1;354:75-83. doi: 10.1016/j.ijcard.2022.02.012. Epub 2022 Feb 12. |
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sharing of results after obtaining
5years
Clinical trials
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| ID | Term |
|---|---|
| D066126 | Cardiotoxicity |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Correlation between the left ventricular myocardial dysfunction is defined by FeVG < 55% and the left global longitudinal 2D strain expressed in percentage and measured during the previous SpeckleAnthra study |
| 5 years |
| Death secondary to toxic cardiomyopathy | Correlation between the rate of patients died with a toxic cardiomyopathy and the left global longitudinal 2D strain expressed in percentage and measured during the previous SpeckleAnthra study | 5 years |
Troponin T is a biological markers of cardiotoxicity obtained in a standard blood test analysis and expressed in ng/ml. normal troponin value is between 0 and 0.04 ng/mL
| The day of inclusion |
| NT-pro-BNP on the experimental group | NT-pro-BNP (N terminal-pro-brain natriuretic peptides) is a biological markers of cardiotoxicity obtained in a standard blood test analysis and expressed in pg/ml. Normal NT-proBNP value is < 400pg/ml | The day of inclusion |
| Known risk factors for cardiotoxicity | To assess the effect of known risk factors for anthracycline cardiotoxicity, young age at administration will be collected | the day of inclusion |
| Known risk factors for cardiotoxicity | To assess the effect of known risk factors for anthracycline cardiotoxicity, female gender, will be collected | the day of inclusion |
| Known risk factors for cardiotoxicity | To assess the effect of known risk factors for anthracycline cardiotoxicity, association with mediastinal radiotherapy will be collected | The day of inclusion |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| D064419 | Chemically-Induced Disorders |
| D011832 | Radiation Injuries |
| D014947 | Wounds and Injuries |